Health News Roundup: FDA website shows limited availability of some doses of Lilly's Mounjaro; Novo Nordisk's parent to buy Catalent for $16.5 billion to boost Wegovy supply and more
Reuters first reported on Monday that Switzerland-based Novartis was in advanced talks to acquire MorphoSys, leading to the German biotech firm's shares surging more than 40%. J&J's immune disorder drug succeeds in mid and late-stage studies Johnson & Johnson's experimental drug to treat two autoimmune disorders helped relieve symptoms when tested in adult patients in mid-stage and late-stage trials, the company said on Monday.
Following is a summary of current health news briefs.
Genetic test maker Invitae prepares for bankruptcy - WSJ
Genetic test maker Invitae is preparing to file for bankruptcy within weeks, the Wall Street Journal reported onMonday, according to people familiar with the matter. Shares of the San Francisco-based company tumbled 69% to hit a record low of 11 cents after the report. An Invitae spokesperson told Reuters that the company did not comment on market rumors and speculation and said the Board of Directors had formed a special committee in November to improve its capital structure. The Softbank-backed company is working with FTI Consulting and law firm Kirkland & Ellis to explore strategic options, including bankruptcy, to address $1.5 billion of debt on its balance sheet, according to the report.In a regulatory filing in November, the company had flagged concerns about its ability to stay afloat. Invitae said it needed to secure additional funding to support ongoing operations or to address its debt obligations. The company provides genetic testing services for various diseases and cancers in and outside the United States.
4D Molecular soars as mid-stage data for eye disease therapy 'checks all boxes'
Shares of 4D Molecular Therapeutics more than doubled on Monday after the therapy developer reported results from a mid-stage trial of its eye disease therapy. The stock hit an over two-year high of $35.61 after the company released interim data on Saturday from the trial that tested the gene therapy, 4D-150, in patients with wet age-related macular degeneration (AMD), a leading cause of vision loss among older adults.
Vertex's triple combo cystic-fibrosis drug meets main late-stage study goals
Vertex Pharmaceuticals' experimental cystic-fibrosis treatment met all of its main goals in a late-stage study when tested in patients aged 12 years and older, the company said on Monday. The once-daily triple combination treatment, called vanza triple, met the primary goals of the study's two 52-week trials and was non-inferior for lung function to Trikafta, the company's top-selling drug for the disorder, with a comparable safety profile.
Novartis to acquire cancer-centric MorphoSys for $2.9 billion
Drugmaker Novartis AG said on Monday it will acquire MorphoSys AG, a developer of cancer treatments, for 2.7 billion euros ($2.9 billion), adding a promising rare bone-marrow cancer treatment candidate to its portfolio. Reuters first reported on Monday that Switzerland-based Novartis was in advanced talks to acquire MorphoSys, leading to the German biotech firm's shares surging more than 40%.
J&J's immune disorder drug succeeds in mid and late-stage studies
Johnson & Johnson's experimental drug to treat two autoimmune disorders helped relieve symptoms when tested in adult patients in mid-stage and late-stage trials, the company said on Monday. The drug, nipocalimab, significantly reduced symptoms of generalized myasthenia gravis (gMG) in a late-stage study, and in a mid-stage study helped reduce Sjögren's disease severity, J&J said.
US appeals court finds Bayer not shielded from Roundup lawsuit
A U.S. appeals court on Monday refused to dismiss a Georgia doctor's lawsuit claiming that Bayer AG's Roundup weedkiller caused cancer, the latest setback in the German company's efforts to fend off thousands of similar cases carrying potentially billions of dollars in liability. A three-judge panel of the Atlanta-based 11th U.S. Circuit Court of Appeals rejected Bayer's argument that federal regulators' approval of Roundup shielded the company from being sued under state law for failing to warn consumers of the product's risks. Several other appeals courts had previously reached the same conclusion in similar lawsuits.
South Carolina woman sues over state's six-week abortion ban
A South Carolina woman, along with Planned Parenthood, on Monday filed a lawsuit asking a court to rule that state's abortion ban applies after about nine weeks of pregnancy, not six, saying that the law's language based on fetal "heartbeat" is ambiguous. Plaintiff Taylor Shelton in her lawsuit said the law's ban on abortion after "cardiac activity, or the steady and repetitive rhythmic contraction of the fetal heart" is ambiguous because it could mean either the first detectable electrical activity, around six weeks, or the formation of the heart's chambers, after nine weeks.
Promising early data details on Amgen weight-loss drug published
Animal and early-stage human trial data for Amgen's experimental obesity drug published in a medical journal showed that it promoted significant weight loss with an acceptable safety profile, the company said on Monday. The dataset published in Nature Metabolism details outcomes and adverse events for the 49 patients in the Phase 1 trial of the drug, maridebart cafraglutide. Trial participants received different doses of the drug ranging from 21 milligrams to 840 mg. Patients in the study were obese, but did not have other underlying health conditions such as diabetes.
Novo Nordisk's parent to buy Catalent for $16.5 billion to boost Wegovy supply
Novo Nordisk notched a win on Monday in its race to boost output of its popular obesity drug Wegovy, with its parent company announcing it was buying Catalent, a key manufacturing subcontractor of the product, for $16.5 billion. Kasim Kutay, CEO of Novo Holdings, told Reuters the deal is core to his company's strategy to support Novo Nordisk and enable the drugmaker to expand fill-finish capacity to meet soaring demand for Wegovy.
FDA website shows limited availability of some doses of Lilly's Mounjaro
The U.S. Food and Drug Administration's (FDA) website showed that three higher doses of Eli Lilly's diabetes drug, Mounjaro, would be available only in limited amounts through early March 2024, due to increased demand. According to the health regulator's website, 10, 12.5 and 15 milligram doses of the injection will have limited availability, while lower doses of Mounjaro were shown to be available.

